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510(k) Data Aggregation

    K Number
    K181097
    Device Name
    Cook Cystostomy Catheter Set
    Manufacturer
    Cook Incorporated
    Date Cleared
    2019-01-18

    (267 days)

    Product Code
    KOB
    Regulation Number
    876.5090
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K014002,K140085
    Why did this record match?
    Reference Devices :

    K014002, K140085

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Cook® Cystostomy Catheter Set is used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks.

    Device Description

    The Cook® Cystostomy Catheter Set is composed of a single-lumen silicone catheter available in 8 to 12 French with a working length of 54 centimeters, a trocar stylet with access sheath having an outer diameter of 10 to 14 French with a length of either 11 or 11.2 centimeters, a drainage adapter with stopcock available in 12 to 16 gauge and a soft low-profile silicone catheter support with pull tie. The set is supplied sterile, intended for one-time use only, and packaged in a peelopen pouch with a three-year shelf life.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device called the Cook® Cystostomy Catheter Set. It does not describe an AI/ML powered device, nor does it contain information about diagnostic study performance acceptance criteria or a study proving that an AI/ML powered device meets those criteria.

    Therefore, I cannot provide the requested information, which is specific to AI/ML device performance studies, based on the provided text. The document details the substantial equivalence of a physical medical device (catheter set) to predicate devices through physical and biological testing, not through AI/ML model performance evaluation.

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